A Single-dose, Randomized, Open-label, Two-period Crossover Bioequivalence Study Comparing a Fixed-Dose Pediatric Combination of Lamivudine and Stavudine Tablet for Oral Suspension with Individual Liquid Formulations in Healthy Adult Male Volunteers

2011 ◽  
Vol 59 (02) ◽  
pp. 104-108
Author(s):  
Tausif Monif ◽  
Simrit Reyar ◽  
Hari Tiwari ◽  
Sudhakar Tippabhotla ◽  
Arshad Khuroo ◽  
...  
Keyword(s):  
Single Dose ◽  
Adult Male ◽  
Healthy Adult ◽  
Bioequivalence Study ◽  
Oral Suspension ◽  
Fixed Dose ◽  
Open Label ◽  
Male Volunteers ◽  
Healthy Adult Male

scholarly journals Bioequivalence evaluation of two capsule formulations of amoxicillin in healthy adult male bangladeshi volunteers: A single-dose, randomized, open-label, two-period crossover study

2008 ◽  
Vol 69 (6) ◽  
pp. 504-513 ◽  
Author(s):  
Ashik Ullah ◽  
Mohammad Abul Kalam Azad ◽  
Rebeka Sultana ◽  
Maruf Mohammad Akbor ◽  
Ahasanul Hasan ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Adult Male ◽  
Healthy Adult ◽  
Open Label ◽  
Healthy Adult Male

A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults

2017 ◽  
Vol 24 (3) ◽  
pp. 414-419 ◽  
Author(s):  
Carolyn Sikes ◽  
Jeffrey G. Stark ◽  
Russ McMahen ◽  
Dorothy Engelking
Keyword(s):  
Single Dose ◽  
Extended Release ◽  
Healthy Adult ◽  
Bioequivalence Study ◽  
Oral Suspension ◽  
Pharmacokinetic Parameters ◽  
Open Label ◽  
Adult Participants ◽  
Study Results ◽  
Adult Volunteers

Objective: The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. Method: In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for d- and l-amphetamine concentrations, and pharmacokinetic parameters Cmax, AUC0-5, AUC5-last, and AUCinf were calculated to determine bioequivalence. Safety was monitored throughout the study. Results: The 90% confidence intervals (CIs) for the log-transformed Cmax, AUC0-5, AUC5-last, and AUCinf fell within the accepted 80% to 125% range for establishing bioequivalence for d- and l-amphetamine. The most common adverse events were nausea and decreased appetite. Conclusion: AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.

The effect of ranitidine on the pharmacokinetics of rosiglitazone in healthy adult male volunteers

2002 ◽  
Vol 24 (7) ◽  
pp. 1062-1071 ◽  
Author(s):  
Ann K. Miller ◽  
Robert A. DiCicco ◽  
Martin I. Freed
Keyword(s):  
Adult Male ◽  
Healthy Adult ◽  
Male Volunteers ◽  
Healthy Adult Male
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